High Volumes of Hypertonic Saline and Chest Physiotherapy in CF Patients

Overview

Background Nebulised hypertonic saline (HS) is an established basic airway clearance treatment in Cystic Fibrosis (CF). However, there is scarce evidence regarding the practical implementation and administration of different HS volumes, including physiotherapy and aspects of breathing pattern.

The aim of the study was to implement standardised and age-adjusted nebulised volumes of hypertonic saline in cystic fibrosis patients, included in physiotherapy and lung drainage techniques.

Full Title of Study: “Establishment and Implementation of Nebulised High Volumes of Hypertonic Saline in Cystic Fibrosis Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2011

Detailed Description

Aims: To establish a safe, efficient routine for implementation of HS in daily treatment and to investigate the efficiency and tolerance of high volumes of HS integrated with chest physiotherapy.

HS was given twice daily with volumes of 4,5 ml in children aged 0-5 years, 6 ml at age 6-16 years and 9 ml at age > 16 years. The protocol included guidance of standardized breathing pattern, upright and sideways positioning and voluntary cough.

Interventions

  • Device: Hypertonic saline
    • 1 mmol/ml hypertonic saline given from (small children) 1,5 ml in 3 positions twice daily increasing to (children) 2 ml in 3 positions twice daily and up to (adults) 3 ml in 3 positions twice daily
  • Procedure: Physiotherapy

Arms, Groups and Cohorts

  • Experimental: Physiotherapy and hypertonic saline
    • Chest physiotherapy integrated with inhalation of hypertonic saline

Clinical Trial Outcome Measures

Primary Measures

  • Tolerance and safety of high volumes of inhaled hypertonic saline measured by forced expiratory volume at one second
    • Time Frame: 24 months

Secondary Measures

  • Implementation of nebulised high volumes of hypertonic saline in cystic fibrosis patients
    • Time Frame: 24 months
    • Establishment of a standardized routine of nebulised high volumes of hypertonic saline including chest physiotherapy in cystic fibrosis patients

Participating in This Clinical Trial

Inclusion Criteria

  • Cystic fibrosis

Exclusion Criteria

  • Non-adherence

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Haukeland University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Stian Hammer, Principal Investigator, Dept. of Physiotherapy, Haukeland University Hospital, Bergen, Norway

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.